MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for ZOOM STRETCHER, PRIME X 1125 1125000000X manufactured by Stryker Medical-kalamazoo.
[177423800]
The customer reported that a porter using electric trolley on (b)(6) when power failed (zoom disengaged during use) and the porter took all the weight of trolley and patient. Another porter assisted in the safe transfer of the patient. The incident caused porter a 2-3 month absence due to back pain. The porter has now returned to work on light duties and continues to receive physiotherapy.
Patient Sequence No: 1, Text Type: D, B5
[182486092]
The awareness date has been updated to reflect the date stryker became aware of the incident.
Patient Sequence No: 1, Text Type: N, H10
[182486093]
The customer reported that a porter using electric trolley on north street when power failed (zoom disengaged during use) and the porter took all the weight of trolley and patient. Another porter assisted in the safe transfer of the patient. The incident caused porter a 2-3 month absence due to back pain. The porter has now returned to work on light duties and continues to receive physiotherapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00298 |
| MDR Report Key | 9655671 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-31 |
| Date of Report | 2020-02-04 |
| Date of Event | 2018-11-17 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-01-31 |
| 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. KRISTEN CANTER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM STRETCHER, PRIME X |
| Generic Name | STRETCHER, WHEELED, POWERED |
| Product Code | INK |
| Date Received | 2020-01-31 |
| Model Number | 1125 |
| Catalog Number | 1125000000X |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |