MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-02 for RESQPUMP manufactured by .
[137700641]
The pump arrived with signs of normal wear and tear. There was no indication of modification or misuse of the device. The clicking upon decompression was confirmed as reported. The clamshell was opened to get access to the spring subassembly hole. Although the micrometer had to be held at a slight angle, the measurements were consistent (11. 12, 11. 18, 11. 29 and 11. 17) and all well below the current specification of 12. 4 +/- 0. 1 mm. This issue was addressed in late 2015. Reference engineering evaluation report # (b)(4). The correction for the clicking was to widen the spring subassembly hole and rev the drawing to indicate this dimension as critical. Refer to change order (b)(4). This pump was built prior to implementation of the new drawing.
Patient Sequence No: 1, Text Type: N, H10
[137700642]
This resqpump was identified during the daily check of the device and not during patient care. The resqpump is making a "clicking" noise when compressing and decompressing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2019-00001 |
| MDR Report Key | 8384636 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-02 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Manufacturer G1 | ADVANCED CIRCULATORY |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2019-03-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-02 |