MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-05-26 for C SERIES CARRY BAR- SS 360755 manufactured by Prism Medical.
[5916752]
The patient was put in a sling and was attached to a ceiling lift. When the patient was about 1 1/2 ft. Above the bed, the carry bar cracked and broke, causing the patient to drop into bed. The carry bar fell onto the patient's abdomen. The caregiver has over 30 years of nursing experience.
Patient Sequence No: 1, Text Type: D, B5
[13389247]
This incident is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[27246829]
The broken plastic insert was reconstructed with glue and reconstructed part indicated deeper than normal indentation on inside face of plastic inserts, indicating use at a higher load (more than 60-70% of swl) or repeated lifting at an angle. Conclusions/recommendations: recommend ongoing evaluation of (b)(4) rev b carry bars with molded inserts to assess and further evaluate the effect of long term use on the molded inserts especially with units used at higher loads or repeatedly exposed to angular lifting during their service life.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007802293-2015-00014 |
| MDR Report Key | 4812349 |
| Report Source | 01,08 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-04-23 |
| Date Mfgr Received | 2015-04-24 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | STEVE KILBURN |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C SERIES CARRY BAR- SS |
| Generic Name | CARRY BAR |
| Product Code | FMR |
| Date Received | 2015-05-26 |
| Returned To Mfg | 2015-05-15 |
| Model Number | 360755 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISM MEDICAL |
| Manufacturer Address | MARYLAND HEIGHTS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-26 |