Affinity® 4 Birthing Bed P3700ERecalls & reported problems
Hill-Rom, Inc. · Hospital Bed · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Hill-Rom Affinity 4 birthing bed is a hospital bed for obstetric use. Most reports describe the bed moving unexpectedly, and some describe material splitting or tearing and activation problems. There are 258 reports, with no deaths and 3 injuries. 1 recall is open, begun in May 2025, over poor crimp connections on actuator wires that could stop the bed or its foot section from lowering.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 255
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 00887761000896), received between May 24, 2021 and Sep 16, 2026 — classified as 2 injuries, 253 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (171 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 6, 2025Open, Classified
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Z-1816-2025 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Unintended Movement171
- Material Split, Cut or Torn55
- Activation Problem19
- Intermittent Continuity2
- Adverse Event Without Identified Device or Use Problem1
- Collapse1
- Defective Component1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions252
- Ambulation or Postural Difficulties1
- Distress1
- Fall1
- Hypoesthesia1
- Insufficient Information1
- Muscle Weakness/Atrophy1
- Nerve Damage1
Recent adverse event reports
The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Intermittent Continuity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796845 ↗MalfunctionSep 15, 2026Unintended Movement
Baxter received a report that the AFFINITY IV had brakes not holding while in brake position. The process step during which this occurred was unknown. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775116 ↗MalfunctionSep 1, 2026Unintended Movement
Baxter received a report that the AFFINITY 4 BED FRAME had brakes not holding while in brake position. This occurred before use. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552657 ↗MalfunctionAug 28, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50489090 ↗MalfunctionAug 26, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457461 ↗MalfunctionAug 18, 2026Unintended Movement
Baxter received a report that AFFINITY 4 BED FRAME had brakes not holding while in brake position. This occurred during Baxter servicing/testing. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291017 ↗MalfunctionAug 14, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261382 ↗MalfunctionAug 12, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226515 ↗MalfunctionAug 11, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202307 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176511 ↗MalfunctionAug 7, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176079 ↗MalfunctionAug 6, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165709 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Ambulation or Postural Difficulties; Distress; Hypoesthesia; Muscle Weakness/Atrophy; Nerve Damage; Neuropathy
MAUDE report 50148731 ↗MalfunctionAug 4, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131203 ↗MalfunctionAug 3, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122182 ↗MalfunctionAug 3, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121414 ↗MalfunctionJul 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068696 ↗MalfunctionJul 28, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063756 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058691 ↗MalfunctionJul 27, 2026Unintended Movement
Baxter received a report stating that AFFINITY 4 BED FRAME backrest would rise on its own as soon as it was plugged into the power outlet. The process step at which the issue occurred was not specified. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027207 ↗MalfunctionJul 16, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25844236 ↗MalfunctionJul 13, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803394 ↗MalfunctionJul 8, 2026Unintended Movement
BAXTER RECEIVED A REPORT THAT AFFINITY 4 BED FRAME HAD BRAKES NOT HOLDING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753286 ↗MalfunctionJul 3, 2026Collapse
BAXTER RECEIVED A REPORT THAT AFFINITY 4 BED FRAME HAD BED FRAME COLLAPSE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709162 ↗MalfunctionJul 2, 2026Unintended Movement
BAXTER RECEIVED A REPORT THAT AFFINITY 4 BED FRAME HAD BRAKES NOT HOLDING WHILE IN BRAKE POSITION. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25700270 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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