VERSAFLO HEADCOVER WITH INTEGRATED HEAD SUSPENSION
Received Feb 9, 2021 · Event occurred Jun 30, 2020
Report 11300456 · MDR key 11300456
Device
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SINCE THE COVID PANDEMIC, HOSPITAL PURCHASED PERSONAL PROTECTIVE EQUIPMENT KNOWN AS POWERED AIR-PURIFYING RESPIRATORS (PAPRS) IN ORDER TO CARE FOR PATIENTS WITH COVID. ICU, PACU, SURGERY CENTER, OPERATING ROOM AND 7B THAT HAS BEEN DESIGNATED AS COVID PATIENT AREAS USE THESE DEVICES. IT HAS COME TO OUR ATTENTION THAT DUE TO BAD DESIGN OF THE BATTERY PACK, THE CLIP THAT LATCHES ON TO THE RESPIRATOR KEEPS BREAKING AND CAUSES THE BATTERIES TO DROP. WE HAVE SEVERAL BATTERY PACKS THAT NEED TO BE REPLACED BUT ARE BACK ORDERED BY MANUFACTURER WITH NO ESTIMATED TIME OF ARRIVAL. THE MANUFACTURER MAY NEED A REVISION OF THEIR DESIGN AND COME UP WITH BETTER SECURING BATTERY PACK.
Description of Event or Problem
SINCE THE COVID PANDEMIC, HOSPITAL PURCHASED PERSONAL PROTECTIVE EQUIPMENT KNOWN AS POWERED AIR-PURIFYING RESPIRATORS (PAPRS) IN ORDER TO CARE FOR PATIENTS WITH COVID. ICU, PACU, SURGERY CENTER, OPERATING ROOM AND 7B THAT HAS BEEN DESIGNATED AS COVID PATIENT AREAS USE THESE DEVICES. IT HAS COME TO OUR ATTENTION THAT DUE TO BAD DESIGN OF THE BATTERY PACK, THE CLIP THAT LATCHES ON TO THE RESPIRATOR KEEPS BREAKING AND CAUSES THE BATTERIES TO DROP. WE HAVE SEVERAL BATTERY PACKS THAT NEED TO BE REPLACED BUT ARE BACKORDERED BY MANUFACTURER WITH NO ESTIMATED TIME OF ARRIVAL. THE MANUFACTURER MAY NEED A REVISION OF THEIR DESIGN AND COME UP WITH BETTER SECURING BATTERY PACK.
Description of Event or Problem
SINCE THE COVID PANDEMIC, HOSPITAL PURCHASED PERSONAL PROTECTIVE EQUIPMENT KNOWN AS POWERED AIR-PURIFYING RESPIRATORS (PAPRS) IN ORDER TO CARE FOR PATIENTS WITH COVID. ICU, PACU, SURGERY CENTER, OPERATING ROOM AND 7B THAT HAS BEEN DESIGNATED AS COVID PATIENT AREAS USE THESE DEVICES. IT HAS COME TO OUR ATTENTION THAT DUE TO BAD DESIGN OF THE BATTERY PACK, THE CLIP THAT LATCHES ON TO THE RESPIRATOR KEEPS BREAKING AND CAUSES THE BATTERIES TO DROP. WE HAVE SEVERAL BATTERY PACKS THAT NEED TO BE REPLACED BUT ARE BACKORDERED BY MANUFACTURER WITH NO ESTIMATED TIME OF ARRIVAL. THE MANUFACTURER MAY NEED A REVISION OF THEIR DESIGN AND COME UP WITH BETTER SECURING BATTERY PACK.