MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for STRYKER PATIENT RECLINER * manufactured by Stryker Medical.
[14885363]
A nurse manager had several complaints from her patients regarding the "rigidity" in the patient recliners. Approximately 8-10 patients/wife have stated that they do not like the new recliners. The patients/wife were quite passionate about their feedback. Specifically, patients have stated:pulley to recline is too hard to manipulatechair abruptly "pops" upchair is too difficult to take out of the recline positiontoo high despite the additional footrest (patient attributes this to his fall)according to the patients, they feel that we should know that this population is older and weaker. Many have stated that they preferred the older chairs with the pull lever on the side. The older recliner chairs were easier for the patient/family to manipulate. ======================manufacturer response for patient recliner chair, stryker patient recliner (per site reporter)======================the representative was notified by the nursing unit manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2578632 |
| MDR Report Key | 2578632 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-05-16 |
| Date of Event | 2012-04-30 |
| Report Date | 2012-05-16 |
| Date Reported to FDA | 2012-05-16 |
| Date Added to Maude | 2012-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER PATIENT RECLINER |
| Generic Name | PATIENT RECLINER CHAIR |
| Product Code | FRJ |
| Date Received | 2012-05-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 3800 E. CENTRE AVE. PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-16 |