MAUDE Adverse Event Report: DATEX-OHMEDA, INC. PANDA IRES WARMER; WARMER, INFANT RADIANT

Model Number	M1112198
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No report of patient involvement.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019.The gehc internal field modification number is fmi (b)(4).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.
Event or Problem Description
The hospital reported that latches on the front panel are broken which could cause a patient fall.There was no report of patient involvement.

• Brand Name: PANDA IRES WARMER
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8930768
• Report Number: 2112667-2019-00405
• Device Sequence Number: 13516322
• Product Code: FMT
• UDI-Device Identifier: 00840682103893
• UDI-Public: 010084068210389321
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1112198
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FMI32067
• Patient Sequence Number: 1