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

Device Problem Mechanical Problem (1384)

Patient Problem Burn(s) (1757)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A supplemental report will be provided after the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

Per the user filed medwatch report: "while an infant was under the infant warmer a screw from the top housing by the warming element fell down on the baby.This resulted in burns to the infant's neck and shoulder.".

Manufacturer Narrative

The 510(k) number updated.Per 21 cfr 806.10 report no.1121732-08/17/16-001-c submitted on 8/17/2016.Ge healthcare inspected the unit at the hospital and conducted tests on the engineering lab units to attempt to reproduce the reported issue of the screw falling from the heater head assembly.Ge healthcare further performed detailed engineering analysis and experiments on engineering lab units at the screw location to identify and confirm (with an intentionally loose screw) that the inherently safe design built into the heater head assembly will prevent the screw from falling on the bed under normal operating conditions.Following the event, the hospital reported that the unit was removed from service on (b)(6) 2016 for investigation.As of june 22, 2016 the unit had not been repaired and had not been put back in service.The hospital does not rely on ge healthcare to maintain or service its units, choosing instead to rely on a third party service provider.The hospital's service provider checked all remaining similar units at the hospital for loose screws.During the check the hospital found one other unit with one screw that was loose by a thread at the same screw location as the one that reportedly fell on the unit reported in the incident.According to the hospital, this additional unit was repaired (by the hospital's in-house service provider) by applying loctite to the screw, which is not approved or recommended by ge healthcare.Ge healthcare's investigation revealed no evidence of unusually rough transport within the hospital environment as observed during the on-site visit.Ge healthcare's review of the service history provided by the hospital did not reveal any documented service events on the unit that would have caused the disassembly and/or loosening of the screw under question.Testing performed in the engineering lab on a ge healthcare owned panda iws warmer to simulate lifetime use did not cause the screw to fall from the heater head assembly.Engineering analysis confirmed that the front plate that was stuck on a threaded screw would not displace the heater rod during normal expansion, or cause the screw to fall.This analysis confirmed that the screw cannot fall without external interaction.In addition, repeated thermal cycling of the heater head to simulate lifetime use, and repeated movement of the heater head assembly, did not cause the screw to fall.Marks found on the screw head and heater rod, and a bent cable attached to the lug on the south end heater rod connection, confirm the root cause to be inadequate maintenance of the heater rod assembly.

• Brand Name: PANDA WARMER
• Type of Device: INFANT RADIANT WARMER
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel MD 20723
• Manufacturer (Section G): OHMEDA MEDICAL; 8880 gorman rd; laurel MD 20723
• Manufacturer Contact: james giles ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 5709642
• MDR Text Key: 46912798
• Report Number: 1121732-2016-00001
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1121732-08/17/16-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Weight: 3