MAUDE Adverse Event Report: INTEGRA YORK, PA INC. BATTERY CHARGER, SINGLE BAY; LIGHTING

Catalog Number 90523

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A regulatory affairs senior specialist reported on behalf of the physician that the 90523 battery charger, single bay was overheating and had a melting plastic (burning smell).The product was discarded by the customer.The event date is unclear.It was unknown if there was patient contact, or a surgery delay, however there was no adverse event reported.Additional information received on 11jun2019 noted that there was no mention of the presence or absence of smoke.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.The serial/lot number was not provided to perform device history record review.Failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.Device identifier: (b)(4).

Manufacturer Narrative

Additional information received on 26aug2019 indicating that there was no delay in the procedure due to product problem.The charger was not used during surgery.After the product problem occurred, they stopped using the battery charger and discarded it.No patient impact or adverse consequence reported.

• Brand Name: BATTERY CHARGER, SINGLE BAY
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8699811
• MDR Text Key: 148021701
• Report Number: 2523190-2019-00082
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 90523
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 08/26/2019
• Supplement Dates FDA Received: 06/25/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1