MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-02 for INVACARE PROPEL BACK 18 IN WIDE AIRPTMBDY18 manufactured by Invacare Rehabilitation Equipment Co..
[32784131]
Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32784132]
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.
Patient Sequence No: 1, Text Type: D, B5
[32787535]
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.
Patient Sequence No: 1, Text Type: N, H10
[32787536]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008262382-2015-01985 |
| MDR Report Key | 5260061 |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE REHABILITATION EQUIPMENT CO. |
| Manufacturer Street | NO.5 WEIXI ROAD, SIP |
| Manufacturer City | SUZHOU JIANGSU 215121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2358-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE PROPEL BACK 18 IN WIDE |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2015-12-02 |
| Returned To Mfg | 2015-12-03 |
| Model Number | AIRPTMBDY18 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE REHABILITATION EQUIPMENT CO. |
| Manufacturer Address | NO.5 WEIXI ROAD, SIP SUZHOU JIANGSU 215121 CH 215121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-02 |