MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-25 for AIR EXPRESS MATTRESS M1000 manufactured by Stryker Medical-kalamazoo.
[109312556]
It was reported that the patient rolled out of bed, hitting her head on a night stand causing a hematoma on the left side of her head. It was further reported that the patient received unknown medical intervention. No further details were given at this time.
Patient Sequence No: 1, Text Type: D, B5
[115810423]
Catalog number has been corrected in tab d. Further, upon investigation it was found that if the mattress had deflated as alleged, the air cells would have deflated evenly with no tilt to one side or the other. Additionally, underneath the air cells of the mattress there is a single, flat layer of foam. If the top half of the mattress had completely deflated, the patient would have been laying on a uniform layer of foam so would not have pushed towards one direction or the other. Given this information, it was determined that it is unlikely that the mattress had caused or contributed to the alleged patient fall. Device not made available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[115810424]
It was reported that the patient rolled out of bed, hitting her head on a night stand causing a hematoma on the left side of her head. It was further reported that the patient received unknown medical intervention. No further details were given at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00504 |
| MDR Report Key | 7546176 |
| Report Source | CONSUMER |
| Date Received | 2018-05-25 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-04-21 |
| Date Mfgr Received | 2018-04-29 |
| Date Added to Maude | 2018-05-25 |
| 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. CHANDA BURGHARD |
| 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 | AIR EXPRESS MATTRESS |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-05-25 |
| Catalog Number | M1000 |
| 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 | 2018-05-25 |