PANDA IRES WARMER Adverse Event — Malfunction (MDR 2112667-2020-01380)
PANDA IRES WARMER Adverse Event — Malfunction (MDR 2112667-2020-01380) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PANDA IRES WARMER; Generic name: WARMER, INFANT RADIANT; Manufacturer: DATEX-OHMEDA, INC..
| Device | PANDA IRES WARMER |
|---|---|
| Generic name | WARMER, INFANT RADIANT |
| Manufacturer | DATEX-OHMEDA, INC. |
| Report number | 2112667-2020-01380 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | UDI # (B)(4). GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 20 MARCH 2019. THE FDA RECALL NUMBER IS Z-1846-2019 & Z-1847-2019. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO INSPECT THE WARMER BEDSIDE PANEL LATCH AREAS. REPLACEMENT OF BROKEN BEDSIDE PANELS WILL BE PROVIDED BY GEHC. A SET OF WARNING LABELS WILL BE SUPPLIED FOR |
| Source | openFDA MAUDE (device adverse events) |
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