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).
[20653068]
It was reported to the manufacturer from distributor via the facility, during a patient transfer from the chair to the bed, the bracket that holds the cradle at the top broke. Two cna's lowered the patient to the bed. No injuries were reported. Follow up investigation revealed that the patient did not receive any injuries. Description provided by the facility indicates that the "dog ear" or mounting bracket that holds the scale to the cradle sheared. Complaint # (b)(4) has been entered into the system by (b)(4) to retrieve the lift back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[20965028]
Suspect medical device info: presence lifter 0912l0803. 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 | 1317256-2012-00002 |
| MDR Report Key | 2549698 |
| Report Source | 06 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-04-06 |
| Date of Event | 2012-02-21 |
| Date Mfgr Received | 2012-03-23 |
| Device Manufacturer Date | 2009-12-01 |
| 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 | Y |
| 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 |