Ventilator, emergency, powered (resuscitator): medical device reports filed with FDA

4,753 reports carry this product code, 1992–2026; 15 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,753
reports with this product code: 0% of all MAUDE reports; 100
reports, 12 months to August 2026: 293 in the 12 months before; 95%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code BTL is FDA's classification for "Ventilator, emergency, powered (resuscitator)" (anesthesiology panel), a class 2 device. 4,753 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

100 reports arrived in the 12 months to August 2026, down 66% from 293 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 (95%), injury (3.5%) and death (0.7%). 15 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Neopuff Infant Resuscitator	1,597	0	0%	99.5%
Pneupac paraPAC plus	700	37	0%	99.3%
Pneupac	397	0	0%	97.1%
Pneupac Parapac Ventilator	254	0	0.4%	94.2%
Pneupac Ventilators Parapac Plus	200	0	1%	98.5%
Giraffe IRS	29	54	0%	100%
Puritan Bennett	3	10	2.2%	66.6%
Ventilator	3	3	7.5%	33.3%
Bear	2	0	2.3%	65.7%
Level One	1	31	1.7%	45.9%
Medfusion 3500 Pump	1	15	0%	99.8%
Octrode Lead Kit, 90cm Length	1	329	0.2%	0.4%
Portex Endotracheal Tubes	1	36	0.4%	82.5%
Portex General Anesthesia Circuits	1	10	0%	99.4%
Uni-Vent Model 731	1	0	0.3%	99.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Fisher & Paykel Healthcare	1,407	29.6%
Smiths Medical International	951	20%
Smiths Medical Asd	642	13.5%
St Paul	249	5.2%
Icu Medical	41	0.9%
Datex-Ohmeda	32	0.7%
Smith S Medical Asd	32	0.7%
Puritan Bennett	5	0.1%
Puritan-Bennett	3	0.1%
Ge Healthcare	2	0%
Oakdale	2	0%
Smiths Medical	2	0%
Becton Dickinson And	1	0%
Maquet	1	0%
St Jude Medical - Neuromodulation	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.7%34

Injury3.5%164

Malfunction95%4,514

Other0.6%28

Not given0.3%13

Who filed

Manufacturer report97.3%4,624

Voluntary report1.3%61

User facility report0%0

Distributor report0%1

Not given1.4%67

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	898	18.9%
Pressure problem	773	16.3%
Device alarm system	303	6.4%
Failure to cycle	253	5.3%
Gas/air leak	170	3.6%
Tidal volume fluctuations	156	3.3%
Mechanical problema mechanical problem	148	3.1%
Defective component	131	2.8%
Loose or intermittent connection	116	2.4%
Detachment of device or device componentpart of the device came off	109	2.3%
Component missing	92	1.9%
No audible alarm	91	1.9%
Defective devicethe device was defective	89	1.9%
Device issuea problem with the device	85	1.8%
Device operates differently than expectedthe device behaved unexpectedly	84	1.8%
Crackthe device cracked	82	1.7%
Defective alarm	75	1.6%
Output problem	73	1.5%
Battery problema problem with the battery	71	1.5%
Noise, audible	68	1.4%

Questions about ventilator, emergency, powered (resuscitator) reports

What is product code BTL?

FDA's classification code for "Ventilator, emergency, powered (resuscitator)", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,753 reports through August 2026, 100 of them in the latest 12 months.

Which brands appear most often?

Neopuff Infant Resuscitator (1,597), Pneupac paraPAC plus (700), Pneupac (397), Pneupac Parapac Ventilator (254) and Pneupac Ventilators Parapac Plus (200). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.