MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. INVACARE PROPEL BACK 18 IN WIDE; CUSHION, WHEELCHAIR

Model Number AIRPTMBDY18

Device Problem Fire (1245)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

The tbm is stating that the dealer now states the base caught on fire, that it could be exaggerated because he sees no indication of fire.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that an odor was observed when the battery box shroud was removed, and there was swelling to the battery housing.However, there was no evidence indicating a fire.This device falls under the battery recall z-2358-2015.The units were recalled due to the batteries used in the invacare pronto air personal transporter power wheelchairs having the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

Event Description

The tbm is stating that the dealer now states the base caught on fire, that it could be exaggerated because he sees no indication of fire.

• Brand Name: INVACARE PROPEL BACK 18 IN WIDE
• Type of Device: CUSHION, WHEELCHAIR
• 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: 5260061
• MDR Text Key: 32784131
• Report Number: 3008262382-2015-01985
• Device Sequence Number: 1
• Product Code: IMP
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AIRPTMBDY18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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
• Removal/Correction Number: Z-2358-2015
• Patient Sequence Number: 1