MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED

Model Number M41SR16B

Device Problems Premature Discharge of Battery (1057); Melted (1385); Smoking (1585)

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

Event Type  No Answer Provided  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.No malfunction.Mdr filed due to keywords "smoke" and "melted" present in complaint.The charger was returned for evaluation, however subsequent testing could not verify the complaint.Inspection of the charger connector pins revealed no heat damage.The charger was connected to a set of batteries and a complete functional charge was completed with no discrepancies.No heat or smoke was observed.The underlying cause of the complaint issue could not be determined after reviewing the documentation in this investigation.

Event Description

The consumer alleges the batteries were not holding a charge.The dealer states when he put the charger on the charging station to test, the third pin on the charger allegedly started to smoke and melted.No injury is alleged.

• Brand Name: PRONTO M41 BLUE BASE 9153645762
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5747587
• MDR Text Key: 48401946
• Report Number: 3008262382-2016-00508
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/20/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M41SR16B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2010
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2010
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68
• Patient Weight: 100