MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-14 for CS5 BED IHCS5 manufactured by Invacare Corporation.
[188199034]
The facility indicated that the affected spot on the bed was very small, and the patient has fragile, thinner skin which played a part in her injury and the need for staples. Photographs of the bed were provided. One of the images shows the elevating section mounting bracket, the part that allegedly contributed to the injury. From the image, it appears that there may be an uneven area on the outer edge of the bracket, but its level of sharpness cannot be determined. The underlying cause of the bracket damage is also unknown. It was requested that the part be returned to invacare for further evaluation, but the facility was unwilling to return the part. The dealer advised that they covered the part with foam to prevent any further injury, and the bed is still in use. The serial number of the bed was requested but not provided. Only a partial serial number was visible from the photographs.
Patient Sequence No: 1, Text Type: N, H10
[188199035]
The dealer reported that a facility alleged that a user cut her leg on a piece of metal located where the ihcs5 bed folds in the middle. The user received staples in her leg as a result of the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00002 |
| MDR Report Key | 9586456 |
| Report Source | OTHER |
| Date Received | 2020-01-14 |
| Date of Report | 2018-10-25 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE CORPORATION |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS5 BED |
| Generic Name | BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE |
| Product Code | LLI |
| Date Received | 2020-01-14 |
| Model Number | IHCS5 |
| Catalog Number | IHCS5 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION |
| Manufacturer Address | ONE INVACARE WAY ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |