MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-04 for POSEY BED 8070 manufactured by Mexico.
[5920235]
As reported from the hospital personnel, a patient was able to rip away the seam and bend the rings attached to quick release buckle and escaped. More information received from nurse at hospital this patient did not receive any injury when they got out of the bed.
Patient Sequence No: 1, Text Type: D, B5
[13505317]
Numerous attempts were made to retrieve the product but has not been returned. Review of the history of the service records for the serial number of this product found it has only been returned once in 2013 for servicing and the age indicates it has been in use since 2012, products such as these are required per the ifu to be completely inspected for any seam damage or rips and tears or broken components. Must be taken out of service if any damage is found. Note: posey instructions for use has a warning statement: never try to rip a panel open as this may damage the access panel or the zipper slider by bending it open. Never use the bed if a zipper slider is bent open or damaged, as this may prevent the zipper from closing securely. Never leave the patient? S bedside until all access panel zippers are securely closed. Test the entire length of each zipper by pressing against the panel near the zipper to make sure it is securely closed and the access panel will not open when pressure is applied. Inspect zipper coils for any kinks or misalignment. Test that all zippers open easily and close securely and there are no gaps or openings when pressure is applied along the entire length of each zipper. Always use zipper pull-tabs and ensure that zippers are fully closed,
Patient Sequence No: 1, Text Type: N, H10
[25342346]
Evaluation of the returned product confirmed the reported issue, the seam that covers the zipper on the inside of the left window has been ripped loose. The rings on the canopy were intact and had no damage. The distributor reported that they replaced the damaged ring prior to returning it. The instructions for use are explicit that the bed should not be used with patients diagnosed with any condition that may cause violent or self-destructive behaviors, as such use could result in damage to the posey bed. Per the ifu: "never leave a patient in the posey bed if there is a risk of self-injury, injury to others or of the bed tipping over, or if the patient tries to damage the bed. Be aware that a sudden mood swing may cause violent or aggressive behavior. Use of the posey bed by an agitated patient or a patient who tries to escape must be approved by the doctor or the idht when tube(s) or line(s) are in use. There is a risk of serious injury or death if the patient becomes entangled (caught up), or disrupts the integrity of a tube or monitoring line. Watch for signs of claustrophobia or a significant increase in stress or physical movement. Remove these patients from the posey bed immediately and notify the doctor. In this case, it was reported that a (b)(6) male with a history of traumatic brain injury intentionally caused the damage to the bed in order to escape the canopy. The device was 32 months old at the time of the event and there is no evidence of a device malfunction or manufacturing deficiency. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. No corrective or preventative actions are necessary.
Patient Sequence No: 1, Text Type: N, H10
[25342347]
Supplemental for device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2015-00045 |
| MDR Report Key | 4819927 |
| Report Source | 05,06 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-06-30 |
| Device Manufacturer Date | 2012-09-30 |
| Date Added to Maude | 2015-06-04 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | POSEY SA DE RL DE C.V. |
| Manufacturer Street | AVE. FERROCARRIL # 16901 BODEGA 64 |
| Manufacturer City | COLONIA RIO, TIJUANA MEXICO 22226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY BED 8070 |
| Generic Name | PATIENT BED WITH CANOPY/RESTRAINTS |
| Product Code | OYS |
| Date Received | 2015-06-04 |
| Returned To Mfg | 2015-06-30 |
| Model Number | 8070 |
| Catalog Number | 8070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEXICO |
| Manufacturer Address | DE R.L. DE C.V. AVE. FERROCARRIL NO. 16901 BODEGA TIJUANA,, MEXICO 22664 US 22664 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |