MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-28 for PANDA IRES WARMER manufactured by Datex-ohmeda, Inc..
[188264213]
Udi_not_required. Legal manufacturer: (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 application to the bedside panels. These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer. An addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use. The addendum will also contain instructions to increase detectability of broken or cracked bedside panels. On june 14, 2019 a letter was sent to customers providing an additional addendum, labels, and wall poster.
Patient Sequence No: 1, Text Type: N, H10
[188264214]
As a result of an inspection that was completed as part of correction and removal z-1846-2019 & z-1847-2019, this system was identified as having the broken latch and/or cracked wall malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2020-01040 |
| MDR Report Key | 9894000 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2019-12-29 |
| Date Mfgr Received | 2019-12-29 |
| Device Manufacturer Date | 2014-07-30 |
| Date Added to Maude | 2020-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WOODWORTH |
| Manufacturer Street | 3030 OHMEDA DRIVE |
| Manufacturer City | MADISON, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1846-2019, Z-1847-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANDA IRES WARMER |
| Generic Name | WARMER, INFANT RADIANT |
| Product Code | FMT |
| Date Received | 2020-03-28 |
| Lot Number | HDJT51729 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DR, MADISON, WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |