MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-10-12 for WHEELCHAIR ACCESSORY IHCSTRPHD manufactured by Carroll Healthcare.
[2213746]
The consumer tried to reposition himself in bed with the trapeze handle, when the handle allegedly pulled away from the bar and hit him in the face. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[9436255]
No rma has been issued for the return of this device. Carroll healthcare [invacare continuing care] bed, model cs fx600, has an accessory trapeze bar model ihcstrphd serial number unknown, was in use at the time of the consumer was hit in the head. The age and height of the consumer is unknown. Invacare provides a user installation instructions part number (b)(4) trapeze installation on cs bed. Doc carroll healthcare inc. The consumer weighs (b)(6) lbs. The amount of weight/force the consumer used to reposition is unknown. On pages 2 and 3 of the installation instructions the following warnings are provided: "safe working load of the standard trapeze is 168 lb. (750 n). Do not exceed 168 lb. (750 n). " "safe working load of heavy duty trapeze is 250 lbs. (1115 n). Do not exceed 250 lb. (1115 n). "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003433498-2011-00015 |
| MDR Report Key | 2287816 |
| Report Source | 08 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-10-10 |
| Date of Event | 2011-09-13 |
| Date Mfgr Received | 2011-09-15 |
| Date Added to Maude | 2012-07-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFF BOND |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE CONTINUING CARE GROUP |
| Manufacturer City | OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR ACCESSORY |
| Generic Name | 890.3910 |
| Product Code | KNO |
| Date Received | 2011-10-12 |
| Model Number | IHCSTRPHD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARROLL HEALTHCARE |
| Manufacturer Address | 994 HARGRIEVE RD LONDON, ONTARIO N6E1P5 CA N6E 1P5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-12 |