Devices › Ventilator, emergency, powered (resuscitator)
Device brand name · Ventilator emergency powered resuscitator
Pneupac paraPAC plus: medical device reports filed with FDA
700 reports name it, 2018–2026. Manufacturer given most often on reports: Smiths Medical International. Product code BTL.
- 700
- device reports naming the brand
- 0% of all MAUDE reports · about 82 a year
- 37
- reports, 12 months to August 2026
- 73 in the 12 months before
- 99.3%
- classified as malfunction
- 95% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 700 reports that name the brand "Pneupac paraPAC plus" (ventilator emergency powered resuscitator), received between January 2018 and August 2026; the manufacturer given most often on reports is Smiths Medical International. Spellings of one product vary from report to report.
37 reports arrived in the 12 months to August 2026, down 49% from 73 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.3%), injury (0.6%) and other (0.1%); across all ventilator, emergency, powered (resuscitator) reports (product code BTL) death is recorded in 0.7% and malfunction in 95%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are pressure problem (11.1%), failure to cycle (10.6%) and device alarm system (8.1%). The patient problems coded most often are no patient involvement, decreased respiratory rate and low oxygen saturation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,753 reports carrying product code BTL. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Pressure problem | 78 | 11.1% | 16.3% |
| Failure to cycle | 74 | 10.6% | 5.3% |
| Device alarm system | 57 | 8.1% | 6.4% |
| Breakthe device broke | 56 | 8% | 18.9% |
| Tidal volume fluctuations | 54 | 7.7% | 3.3% |
| Detachment of device or device componentpart of the device came off | 38 | 5.4% | 2.3% |
| Loose or intermittent connection | 34 | 4.9% | 2.4% |
| Fracturea broken bone | 28 | 4% | 1.2% |
| Component missing | 26 | 3.7% | 1.9% |
| Incorrect, inadequate or imprecise result or readings | 24 | 3.4% | 1.3% |
| Crackthe device cracked | 22 | 3.1% | 1.7% |
| Mechanical problema mechanical problem | 22 | 3.1% | 3.1% |
| Defective component | 21 | 3% | 2.8% |
| Calibration problem | 18 | 2.6% | 1.1% |
| Defective alarm | 18 | 2.6% | 1.6% |
| Gas/air leak | 18 | 2.6% | 3.6% |
| Improper flow or infusion | 16 | 2.3% | 0.8% |
| Gas output problem | 14 | 2% | 0.6% |
| Unable to obtain readings | 13 | 1.9% | 0.6% |
| Infusion or flow problema problem with flow or infusion | 12 | 1.7% | 1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 18 | 2.6% |
| Decreased respiratory rate | 1 | 0.1% |
| Low oxygen saturation | 1 | 0.1% |
| Not applicable | 1 | 0.1% |
| Pneumothoraxa collapsed lung | 1 | 0.1% |
| Respiratory distressdifficulty breathing | 1 | 0.1% |
| Sleep dysfunction | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pneupac paraPAC plus | Product code BTL | All MAUDE reports |
|---|---|---|---|
| Reports | 700 | 4,753 | 26,136,888 |
| Share of that pool | — | 14.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 0.6% | 3.5% | 36.2% |
| Classified as malfunction | 99.3% | 95% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code BTL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Neopuff Infant Resuscitator | 1,607 | 0 | 0% |
| Pneupac | 412 | 0 | 0% |
| Pneupac Parapac Ventilator | 260 | 0 | 0.4% |
| Pneupac Ventilators Parapac Plus | 200 | 0 | 1% |
| Giraffe IRS | 165 | 54 | 0% |
| Puritan Bennett | 503 | 10 | 2.2% |
| Ventilator | 174 | 3 | 7.5% |
| Bear | 600 | 0 | 2.3% |
| Level One | 231 | 31 | 1.7% |
| Medfusion 3500 Pump | 636 | 15 | 0% |
| Octrode Lead Kit, 90cm Length | 3,742 | 329 | 0.2% |
| Portex Endotracheal Tubes | 223 | 36 | 0.4% |
| Portex General Anesthesia Circuits | 363 | 10 | 0% |
| Uni-Vent Model 731 | 3,305 | 0 | 0.3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Pneupac paraPAC plus reports
How many FDA reports name Pneupac paraPAC plus?
700 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 37 in the latest 12 months.
What kinds of events are reported?
malfunction (99.3%), injury (0.6%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pressure problem (11.1%), failure to cycle (10.6%), device alarm system (8.1%), break (8%) and tidal volume fluctuations (7.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pneupac paraPAC plus was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.