MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Positioning Failure (1158); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2015 for investigation.Investigation results as follows: visual inspection: during visual inspection no damage was observed to the housing, however the battery lock was bent.Archive data log: a review of the archive data log was not able to be downloaded due to the autopulse platform kept rebooting.Functional testing: the autopulse platform passed all functional testing.Based on the investigation, it was observed that: the lifeband was loose, which confirmed the reported issue of "hearing clicking when the autopulse was turned on." the channel roller assembly was replaced to resolve the issue.However, the reported issue of "the lifeband will not move and it looks like the gear is locked up and will not move", was not verified.The drive shaft is rotating on both sides freely without any problems.The processor board (pdb) was found to be faulty, which confirmed the reported issue of "red light on the display but no error messages." the pdb was replaced to remedy the issue.In summary, the customer's reported complaint of "that when the autopulse was powered on, a clicking sound was heard and a red light on the display is visible, however there is no error message" was confirmed.It was found that the processor board was faulty and needed replacing to remedy the display issue.The complaint of "the lifeband will not move and it appears that the gear is locked and will not move" was not confirmed.Unrelated to the reported complaint, it was observed that the lifeband was falling off of the channel roller assembly and the battery lock was bent.The channel roller assembly and the batter lock were replaced.The autopulse platform passed final testing.

Event Description

It was reported that during a shift check the autopulse platform s/n (b)(4) was powered on and clicking sound was heard.Red lights were displayed, however no error message was visible, also the lifeband would not move and it appeared that the gear was locked.No patient involved.No further information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5286594
• MDR Text Key: 33197220
• Report Number: 3010617000-2015-00661
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1