MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for NARA, DOMESTIC 4402000001 manufactured by Stryker Medical-kalamazoo.
[111234387]
It was reported that the bassinet mattress had overinflated due to being in the high altitude. The customer received 36 bassinets and all mattresses experienced the overinflation issue. Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet. No adverse consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
[131584989]
Stryker medical notified fda of field action (b)(4) on (b)(4) 2018.
Patient Sequence No: 1, Text Type: N, H10
[131584990]
It was reported that the bassinet mattress had overinflated due to being in the high altitude. The customer received 36 bassinets and all mattresses experienced the overinflation issue. Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet. No adverse consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00535 |
| MDR Report Key | 7593475 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-05-15 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2018-06-12 |
| 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. MARY KLAVER |
| 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 |
| Removal Correction Number | PR 1814402 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NARA, DOMESTIC |
| Generic Name | BASSINET, HOSPITAL |
| Product Code | NZG |
| Date Received | 2018-06-12 |
| Catalog Number | 4402000001 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-12 |