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

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2020

Event Type  malfunction  

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 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.

Event Description

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.

• Brand Name: PANDA IRES WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: jason kelly ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 11101344
• MDR Text Key: 225806392
• Report Number: 2112667-2020-03674
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2020
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: SEEH10
• Patient Sequence Number: 1