NA 530.510Recalls & reported problems
Synthes GmbH · WATER BATH HEATER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587057187), received between Jan 24, 2019 and Jan 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Intermittent Loss of Power” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Intermittent Loss of Power1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2019Mechanical Problem; Intermittent Loss of Power; Mechanical Problem; Intermittent Loss of Power
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE WATER BATH HEATER WOULD NOT GO INTO STANDBY MODE OR WILL NOT INDICATE IT IS READY FOR USE. PATIENT INVOLVEMENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) WATER BATH HEATER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8275920 ↗
Other BATH, INCUBATORS/WATER, ALL devices
- BD Kiestra™ ReadA 446948BD Kiestra B.V. · BATH, INCUBATORS/WATER, ALL1 recall0 reports
- NA 05.725.010Synthes GmbH · BATH, INCUBATORS/WATER, ALL4 reports
- BD Kiestra™ ReadA™ Compact 447206BD Kiestra B.V. · BATH, INCUBATORS/WATER, ALL2 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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