FDA Adverse Event
Malfunction
Summary report: N
AIR PRO
MDR report key: 17532064
·
Received August 12, 2023
Report
- Report Number
- MW5138974
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- July 1, 2016
- Manufacturer
- BLUE CHIP MEDICAL 7-11 SUFFERN PI#2, SUFFERN, NY 1
- Product Code
- FNM
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE CALLER SPOKE WITH TECH SERVICES AND NOT WITH CSCS. THE CALLER STATED THE AIR MATTRESS WILL DEFLATE DUE TO THE FACT IT KEEPS GETTING HOLES. THE CALLER STATED THE MATTRESS IS AN AIR PRO BLUE CHIP. THE CONSUMER WILL CALL HER PROVIDER BACK FOR THE APPROPRIATE MANUFACTURE CONTACT INFORMATION. NO INJURY OR PROPERTY DAMAGE MENTIONED. THE PATIENT IS IN THE BED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783746 | AIR PRO | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | BLUE CHIP MEDICAL 7-11 SUFFERN PI#2, SUFFERN, NY 1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |