MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-11 for HOYER PRESENCE LIFTER WITH SCALE PRESENCE/ SCALE 0909L0276 manufactured by Sr Instruments (scale Manufacturer Only).
[2688796]
It was reported to the manufacturer from distributor via the facility. A resident was being lifted and the bracket broke. The resident ended up on the floor. The last reported weight of the resident was (b)(6), the mounting bracket for the sling bar on the hoyer appears to have sheared. The device is in a locked enclosed area. Follow up investigation revealed that no serious injury to the patient. (b)(4) evaluation consists of review of digital images. It appears that the "dog ear" where the cradle attaches to the scale sheared. Repeated attempts to obtain additional information regarding the event have been ineffectual. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9964641]
Suspect device info: presence lifter 0909l0276. Scale model fg3105 - serial #(b)(4). The scale manufacturer is sr instruments, (b)(4). It was reported to sr instruments from (b)(4) the lift manufacturer is apex healthcare mfg. Inc. , (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317256-2012-00001 |
| MDR Report Key | 2549697 |
| Report Source | 06 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-04-06 |
| Date of Event | 2012-01-24 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2012-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 600 YOUNG ST. |
| Manufacturer City | TONAWANDA NY 14150 |
| Manufacturer Country | US |
| Manufacturer Postal | 14150 |
| Manufacturer Phone | 7166935977 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER PRESENCE LIFTER WITH SCALE |
| Generic Name | PATIENT LIFT WITH SCALE |
| Product Code | FRW |
| Date Received | 2012-04-11 |
| Model Number | PRESENCE/ SCALE |
| Catalog Number | 0909L0276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SR INSTRUMENTS (SCALE MANUFACTURER ONLY) |
| Manufacturer Address | 600 YOUNG ST. TONAWANDA NY 14150 US 14150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-11 |