MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for ISOLIBRIUM SUPPORT SURFACE - D 2972000000 manufactured by Stryker Medical-kalamazoo.
[114014615]
It was reported the users were experiencing a general increase in injuries to the neck, lower back and shoulders as the surface did not allow ease of use with x-ray cassettes. It was further reported that the users did not require time off work and have self-medicated. No patient was affected and no adverse consequence or clinically relevant delay in treatment for the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
[117742716]
It was identified that the customer believes it is difficult to position x-ray cassettes under patients on the mattress. The account manager stated that he is working with the customer to recommend best practices for positioning x-ray cassettes under patients. The serial number could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[117742717]
It was reported the users were experiencing a general increase in injuries to the neck, lower back and shoulders as the surface did not allow ease of use with x-ray cassettes. It was further reported that the users did not require time off work and have self-medicated. No patient was affected and no adverse consequence or clinically relevant delay in treatment for the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00643 |
| MDR Report Key | 7679425 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Date Added to Maude | 2018-07-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| 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 | 0 |
| Brand Name | ISOLIBRIUM SUPPORT SURFACE - D |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IKZ |
| Date Received | 2018-07-11 |
| Catalog Number | 2972000000 |
| Device Availability | N |
| 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 | 2018-07-11 |