MAUDE Adverse Event Report: OHMEDA MEDICAL PANDA IRES WARMER; WARMER, INFANT RADIANT

Model Number M1112198

Device Problems Nonstandard Device (1420); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

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 gehc internal field modification number is (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 Description

The hospital reported that the front flap of baby warmer falls down easily which could cause a patient fall.There was no report of patient involvement.

• Brand Name: PANDA IRES WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD 20723
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8508811
• MDR Text Key: 146343313
• Report Number: 1121732-2019-00015
• Device Sequence Number: 0
• Product Code: FMT
• Reporter Country Code: US
• PMA/PMN Number: K123309
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1112198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2008
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: FMI32067
• Patient Sequence Number: 1