MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-12 for POSEY BED 8070 manufactured by J.t. Posey Company.
[45066545]
Based on the information available there is no allegation of a malfunction or deficiency of the device. The posey bed professional user manual advises that? You must always be able to access the patient quickly in an emergency.? A section is devoted in the user manual to? Emergency patient access and exit? , which describes the steps in detail for accessing a patient in an emergency and advises users to remove the patient from the bed as necessary. A? Guidelines for proper bed location? Checklist is provided for use in assessing the location of the bed prior to leaving the patient? S side. This checklist asks? Can a patient be easily accessed and can the bed be moved to the center of the room to allow access from all four (4) sides in an emergency situation?? Each no must be corrected before allowing a patient to occupy the bed. The posey bed canopy is used with a standard hospital mattress. There is no headboard as the canopy is designed as an enclosed compartment to help reduce the risk of patient entrapment and to provide a safe, controlled environment for patients at extreme risk of injury from a fall. In this case, it was reported that the caregivers were able to access the patient as needed and the patient was removed from the posey bed per the user manual. There is no evidence or allegation that the posey bed contributed to the patient developing cardiac arrest. This submission is based solely on the user facility's reported issue.
Patient Sequence No: 1, Text Type: N, H10
[45066546]
The customer reported that a patient went into cardiac arrest while inside the posey bed. The caregiver brought in a backboard to lie underneath the patient and began to resuscitate. The customer reported that there was an issue with the effectiveness of the backboard due to the softness of the mattress and the fact that there was no headboard to brace the backboard against. The patient was unable to be resuscitated and was removed from the posey bed. The status of the patient is unknown at this time. The exact date of event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00016 |
| MDR Report Key | 5651177 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-12 |
| Date of Report | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-05-12 |
| 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 | WILLIAM HINCY |
| Manufacturer Street | J.T. POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | J.T. POSEY COMPANY |
| Manufacturer Street | 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 910060020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 910060020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2016-05-12 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-05-12 |