Devices › Table, obstetric (and accessories)
Device brand name · Table obstetric and accessories
Affinity 4 Birthing Bed: medical device reports filed with FDA
305 reports name it, 2013–2026. Manufacturer given most often on reports: Baxter Healthcare. Product code KNC.
- 305
- device reports naming the brand
- 0% of all MAUDE reports · about 23 a year
- 144
- reports, 12 months to August 2026
- 97 in the 12 months before
- 98.4%
- classified as malfunction
- 94.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
305 medical device reports received by FDA name the brand "Affinity 4 Birthing Bed" (table obstetric and accessories); the manufacturer given most often on reports is Baxter Healthcare; received from January 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
144 reports arrived in the 12 months to August 2026, up 48% from 97 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 (98.4%), injury (1.3%) and other (0.3%); across all table, obstetric (and accessories) reports (product code KNC) death is recorded in 0% and malfunction in 94.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended movement (54.1%), material split, cut or torn (14.4%) and activation problem (8.2%). The patient problems coded most often are ambulation or postural difficulties, appropriate clinical signs, symptoms and conditions term/code not available and distress. 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 618 reports carrying product code KNC. 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 |
|---|---|---|---|
| Unintended movement | 165 | 54.1% | 44.8% |
| Material split, cut or torn | 44 | 14.4% | 10.8% |
| Activation problem | 25 | 8.2% | 4.9% |
| Device slipped | 18 | 5.9% | 14.2% |
| Unintended head motion | 12 | 3.9% | 0% |
| Device alarm system | 8 | 2.6% | 1% |
| Unintended system motionthe device moved when it should not have | 4 | 1.3% | 4% |
| Collapse | 3 | 1% | 1% |
| Component falling | 2 | 0.7% | 3.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.7% | 1% |
| Intermittent continuity | 2 | 0.7% | 0.5% |
| Activation failure | 1 | 0.3% | 0.2% |
| Component missing | 1 | 0.3% | 0.2% |
| Device inoperablethe device could not be used | 1 | 0.3% | 0.2% |
| Insufficient device problem information | 1 | 0.3% | 0% |
| Material frayed | 1 | 0.3% | 0.2% |
| Mechanical problema mechanical problem | 1 | 0.3% | 0.5% |
| Positioning failure | 1 | 0.3% | 0.3% |
| Sparking | 1 | 0.3% | 0.2% |
| Sticking | 1 | 0.3% | 0.2% |
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 |
|---|---|---|
| Ambulation or postural difficulties | 1 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.3% |
| Distress | 1 | 0.3% |
| Dyspneashortness of breath | 1 | 0.3% |
| Eye irritationeye irritation | 1 | 0.3% |
| Falla fall | 1 | 0.3% |
| Hypersensitivity/allergic reaction | 1 | 0.3% |
| Hypoesthesia | 1 | 0.3% |
| Injurya physical injury | 1 | 0.3% |
| Muscle weakness/atrophy | 1 | 0.3% |
| Nerve damage | 1 | 0.3% |
| Neuropathy | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Affinity 4 Birthing Bed | Product code KNC | All MAUDE reports |
|---|---|---|---|
| Reports | 305 | 618 | 26,136,888 |
| Share of that pool | — | 49.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.3% | 1.9% | 36.2% |
| Classified as malfunction | 98.4% | 94.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 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 KNC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Affinity 4 Bed Frame | 398 | 0 | 0% |
| Affinity 3 | 313 | 0 | 0% |
| Hill-Rom | 241 | 0 | 18.7% |
| Affinity Three Birthing Bed | 197 | 0 | 0% |
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 Affinity 4 Birthing Bed reports
How many FDA reports name Affinity 4 Birthing Bed?
305 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 144 in the latest 12 months.
What kinds of events are reported?
malfunction (98.4%), injury (1.3%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended movement (54.1%), material split, cut or torn (14.4%), activation problem (8.2%), device slipped (5.9%) and unintended head motion (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Affinity 4 Birthing Bed 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.