MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-02 for PARKER BATH AL25110-GB manufactured by Arjo Hosp Equipment Ab.
[5733376]
Initially it was reported by arjohuntleigh's rep that: "client was found unconscious in the water". Caregiver filled footwell of the bath, put client into bath and continued to run water while tilting bath back slightly, caregiver then started to cook client's breakfast, second caregiver walked into home to find client facedown in bath, she immediately called for help and both staff members lifted client out ot the bath and started cpr to resuscitate the client, client came around where they called paramedics and comforted until they attended. The paramedics were called and confirmed she was better to stay in her own environment after they passed her health. Device examination performed with the customer showed that the involved bath is in "excellent condition". Bath operated through all its functions perfectly but when filling autoshop device does not activate so water does not stop until manually operated. The resident was assessed in relation to mobility gallery as "b"- partly capable of performing daily independently and the assistance she requires is not generally physically demanding for the caregiver.
Patient Sequence No: 1, Text Type: D, B5
[13167562]
(b)(6). Add'l info will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00066 |
| MDR Report Key | 4664051 |
| Report Source | 06,07 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-23 |
| Date Facility Aware | 2015-03-23 |
| Date Reported to FDA | 2015-04-01 |
| Date Reported to Mfgr | 2015-04-01 |
| Date Mfgr Received | 2015-03-23 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2015-04-08 |
| 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 | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJO HOSP EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | SELOV 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Product Code | ILM |
| Date Received | 2015-04-02 |
| Model Number | AL25110-GB |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSP EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-02 |